QUALITY SPECIALIST GMP
WHAT IS OFFERED
Be part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.
This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.
ABOUT THE COMPANY
MindCapture supports in the recruitment of this talent for a global biotech company that’s developing, manufacturing and commercializing new cell-based therapies to battle cancer with focus on immunology.
JOB DESCRIPTION
- Responsible for quality, quality processes and audits in a pharmaceutical production environment (aseptic manufacturing)
- Non-conformances and deviations by driving compliance
- Process documentation in support of process operations
- You will provide guidance and find solutions for quality related manufacturing issues
- Supports manufacturing deviations, CAPAs, change controls and complaints
- Review and approve manufacturing procedures and batch records
- Keep in mind the safety policies, quality systems and cGMP requirements
- Support regulatory inspections and audits by ensuring inspection readiness within facilit
REQUIRED COMPETENCES & SKILLS
- Bachelor’s Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 2 years relevant work experience is required, preferably within quality support in clinical manufacturing
- Knowledge of aseptic processing in ISO 5 clean room and biosafety cabinets
- Knowledge of GMP and FDA/EU regulations related to manufacturing of cell-based products
- Great attention to detail and structured/organised mindset to follow procedures
- Capable of working in a team environment with a positive attitude
- Experience with team-based collaborations
- Proactive
- Good written and verbal communication skills, ability to summarize and present results
- Problem-solving mindset
- Strong leadership skills to develop others and support
- Collaborate well with stakeholders (internal and external)
- Strong decision-making ability and think creatively while maintaining compliance and quality
- Ability to manage conflict and issues that arise with internal or external customers
- Working experience in an aseptic manufacturing facility is a plus
- Dutch and English
Important: this challenge is within a shift schedule, with the advantage of working 4 days per week (10 hours/day) with 4 days off. Shifts include routine weekend and evening work as required by the process. This shift system can help you avoid traffic and reduce time spend in the car
